Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:03 AM
Ignite Modification Date: 2025-12-26 @ 12:28 AM
NCT ID: NCT04633460
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected the day of the study visit (the day of the first intervention visit, "Day 1", and the day of the second intervention visit, approximately "Day 8").
Study: NCT04633460
Study Brief: Acute Effects of Exogenous Ketone Ester Administration in Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ketone Ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester Ketone ester: A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis 0 None 1 20 7 20 View
Placebo KE-free solution placebo drink: KE free placebo drink 0 None 0 20 6 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Laryngeal inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Knee pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle cramp NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Breast pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Heart racing NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pain with blood draw NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View